LORAZEPAM - Generic Drug Details

What are the generic drug sources for lorazepam and what is the scope of freedom to operate?

Lorazepam is the generic ingredient in six branded drugs marketed by Almatica, Amneal Pharms, Chartwell Molecular, Hikma, Lupin Ltd, Pharm Assoc, Bedford, Caplin, Epic Pharma Llc, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Ph Health, Pharmobedient, Rising, Watson Labs, Bedford Labs, Roxane, Bausch, Quantum Pharmics, Am Therap, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Halsey, Leading, Mutual Pharm, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Tp Anda Holdings, Usl Pharma, and Warner Chilcott, and is included in seventy-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Lorazepam has thirty-six patent family members in thirty-one countries.

There are eleven drug master file entries for lorazepam. Thirty-six suppliers are listed for this compound.

Summary for LORAZEPAM

International Patents:	36
US Patents:	1
Tradenames:	6
Applicants:	36
NDAs:	72
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	208
Patent Applications:	6,925
Drug Prices:	Drug price trends for LORAZEPAM
Drug Sales Revenues:	Drug sales revenues for LORAZEPAM
What excipients (inactive ingredients) are in LORAZEPAM?	LORAZEPAM excipients list
DailyMed Link:	LORAZEPAM at DailyMed

See drug prices for LORAZEPAM

See drug sales revenues for LORAZEPAM

Recent Clinical Trials for LORAZEPAM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Rochester	PHASE2
Johns Hopkins University	PHASE2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	PHASE2

See all LORAZEPAM clinical trials

Pharmacology for LORAZEPAM

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for LORAZEPAM

Anti-Anxiety Agents

Anticonvulsants

Antiemetics

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for LORAZEPAM

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for LORAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Usl Pharma	LORAZEPAM	lorazepam	TABLET;ORAL	070539-001	Dec 22, 1986		DISCN	No	No
Sandoz	LORAZEPAM	lorazepam	TABLET;ORAL	071195-001	Apr 15, 1988		DISCN	No	No
Sandoz	LORAZEPAM	lorazepam	TABLET;ORAL	071194-001	Apr 15, 1988		DISCN	No	No
Am Therap	LORAZEPAM	lorazepam	TABLET;ORAL	070728-001	Mar 7, 1986		DISCN	No	No
Superpharm	LORAZEPAM	lorazepam	TABLET;ORAL	071247-001	Feb 9, 1987		DISCN	No	No
Ph Health	LORAZEPAM	lorazepam	INJECTABLE;INJECTION	074793-001	Mar 16, 2000		DISCN	No	No

Expired US Patents for LORAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982	4,017,616
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-002	Approved Prior to Jan 1, 1982	4,017,616

International Patents for LORAZEPAM

Country	Patent Number	Title	Estimated Expiration
Japan	2016504390
European Patent Office	2943185
Slovenia	2943185
Argentina	094391
South Korea	20150118119	로라제팜의 지속 방출성 제제 (SUSTAINED RELEASE FORMULATIONS OF LORAZEPAM)
South Korea	102318274

Market Dynamics and Financial Trajectory for Lorazepam

Last updated: January 15, 2026

Summary

Lorazepam, a benzodiazepine used primarily for anxiety, insomnia, and preoperative sedation, remains a significant player in the psychotropic drug market despite increased scrutiny around its dependency potential. This comprehensive analysis examines its current market landscape, emerging trends, regulatory considerations, competitive positioning, and financial trajectory, offering stakeholders a nuanced view of its future prospects.

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Introduction

Lorazepam, marketed under brands such as Ativan, was first introduced by Wyeth (now part of Pfizer) in the 1970s. Its pharmacological profile — high potency, long-standing clinical validation, and broad indications — has cemented its place in psychiatric and anesthetic treatment protocols. However, the evolving regulatory landscape and rising concerns about benzodiazepine abuse have influenced market dynamics.

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Current Market Landscape

Global Market Size and Value

Parameter	2022 Data	Notes
Global Lorazepam Market Size	USD 1.2 billion	Estimated; driven by North America and Europe
Market CAGR (2022-2027)	3.8%	Moderate growth, expected to stabilize post-pandemic
Major Markets	North America, Europe, Asia-Pacific	North America accounting for 55% of sales

Source: IQVIA(1), MarketWatch*(2)

Market Segmentation

Segment	Share (2022)	Key Riders
By Indication	Anxiety (65%), Insomnia (20%), Preoperative sedation (15%)	CNS disorders, aging population, chronic anxiety trends
By Distribution Channel	Hospitals (50%), Outpatient clinics (30%), Retail Pharmacies (20%)	Managed healthcare, outpatient services
By Region	North America (55%), Europe (25%), Asia-Pacific (15%), Rest of World (5%)	Regulatory maturity, prescribing patterns

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Market Drivers and Restraints

Key Drivers

• Rising Prevalence of Anxiety and Sleep Disorders:
  The WHO estimates over 264 million worldwide suffer from depression and anxiety disorders, fueling demand for anxiolytics like Lorazepam (3).

• Established Clinical Efficacy and Safety Profile:
  Lorazepam’s proven track record maintains its therapeutic prominence.

• Expanded Use in Preoperative and Sedation Settings:
  Its rapid onset and efficacy in sedation sustain demand in hospital settings.

Market Restraints

• Regulatory and Prescription Restrictions:
  Numerous countries implement strict controls to curb misuse. For instance, the US DEA classifies Lorazepam as a Schedule IV drug, imposing restrictions on prescribing and dispensing (4).

• Rise of Alternative Therapies:
  Non-benzodiazepine agents, such as SSRIs and newer hypnotics, are increasingly preferred due to lower dependency risk.

• Dependency and Abuse Concerns:
  Rising awareness and scrutiny have led to tighter guidelines, reducing prescribed volumes.

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Regulatory Environment and Impact

Region	Key Regulations	Impact on Market
United States	DEA Scheduling, REMS (Risk Evaluation and Mitigation Strategy)	Restricts prescribing to certain controlled environments; impacts volume
European Union	EMA guidelines, national controls	Similar restrictions, with some countries moving toward buprenorphine alternatives
Asia-Pacific	Varies; some countries lack strict controls	Potential growth area if regulatory laxity persists, but risk of future restrictions

Regulatory Trends

• Moving toward tighter controls for benzodiazepines globally.
• Emphasis on prescription monitoring programs (e.g., US PDMP).
• Potential for emerging abuse-deterrent formulations.

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Competitive Landscape

Major Global Manufacturers

Company	Market Share	Key Products	Strategic Moves
Pfizer (Ativan)	~30%	Lorazepam tablets, injections	Brand dominance, pipeline development for formulations
Mylan (now part of Viatris)	~10%	Generic Lorazepam	Price competition, expanding generic options
Teva Pharmaceuticals	~15%	Generic Lorazepam	Focus on cost-effective generics
Others	Remaining	Various generics and local brands	Regional expansion, niche formulations

Generics and Market Penetration

Generic versions make up approximately 75-80% of the prescribed Lorazepam volume (5), exerting downward pressure on prices, but also expanding access and volume.

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Financial Trajectory

Revenue Analysis (2022-2027)

Year	Estimated Revenue (USD billions)	Comments
2022	1.2	Base year, stable volume, moderate growth
2023	1.24	Slight increase driven by emerging markets
2024	1.28	Market saturation begins; growth driven by volume rather than price
2025	1.3	Regulatory restrictions could impact growth
2026	1.3	Stabilization phase; minor fluctuations
2027	1.3	Plateau; market maturity

Projection based on current CAGR and market constraints.

Pricing Trends

• Generic Price Decline: Approximately 5-10% annually due to increased competition.
• Brand Premiums: Staying stable in select markets where brand loyalty exists.

Demand Forecast

Demand growth expected primarily in emerging markets with less regulatory oversight, potentially offset by declining use in mature markets.

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Comparison with Similar Drugs

Aspect	Lorazepam	Diazepam	Alprazolam
Pharmacodynamics	High potency, intermediate acting	Long acting, low potency	High potency, rapid onset
Contraindications	Respiratory depression, pregnancy	Liver disease, glaucoma	Severe depression, pregnancy
Abuse potential	High (Schedule IV)	High (Schedule IV)	Very high (Schedule IV)
Market Trend	Slight decline expected	Declining due to dependency issues	Slight decline, alternative therapies gaining

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Future Outlook and Strategic Recommendations

Trend	Implication	Strategic Response
Regulatory tightening	Reduced prescriptions, market contraction	Innovate with abuse-resistant formulations; expand into older populations
Rise of digital health tools	Better monitoring may limit misuse	Incorporate prescription monitoring tools; leverage telemedicine
Emerging markets	Untapped growth potential	Local partnerships, price segmentation strategies
Competition from new agents	Potential market share erosion	Diversify portfolio; invest in complementary CNS therapies

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Key Takeaways

• The Lorazepam market remains stable but faces headwinds from regulatory tightening and rising awareness of dependency risks.
• Generics dominate, emphasizing price sensitivity and pressure on margins.
• Growth prospects are strongest in emerging regions with lax regulations.
• The therapy’s clinical effectiveness sustains demand, but alternative anxiolytic agents threaten market share, especially in developed markets.
• Companies should prioritize developing abuse-deterrent formulations, expand into non-Western markets, and closely monitor regulatory landscapes to sustain financial trajectories.

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FAQs

1. What are the primary factors influencing Lorazepam's market growth?
   Rising prevalence of anxiety and sleep disorders, clinical efficacy, and hospital use sustain demand, particularly in regions with emerging healthcare infrastructure.

2. How do regulatory restrictions impact Lorazepam's market?
   Tighter controls, including prescription monitoring and scheduling, limit prescription volumes, especially in North America and Europe, constraining growth.

3. Are there significant substitutes for Lorazepam?
   Yes, non-benzodiazepine anxiolytics such as SSRIs, SNRIs, and newer sleep aids are increasingly replacing Lorazepam due to safety concerns.

4. What is the outlook for Lorazepam in emerging markets?
   These regions present growth opportunities due to less restrictive regulations, expanding healthcare access, and unmet needs.

5. How might innovations address current challenges facing Lorazepam?
   Development of abuse-deterrent formulations, better monitoring solutions, and diversification into alternative CNS therapies can mitigate regulatory and abuse issues.

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Sources

[1] IQVIA. Global Psychiatric Drug Market Report 2022.
[2] MarketWatch. Lorazepam Market Analysis and Forecast 2022-2027.
[3] WHO. Mental Health and Substance Abuse Statistics.
[4] United States Drug Enforcement Administration (DEA). Controlled Substances Scheduling.
[5] Medscape. Lorazepam Prescribing Trends and Market Share.